| Device Type ID | 4474 |
| Device Name | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Regulation Description | Knee Joint Femorotibial Metal/polymer Non-constrained Cemented Prosthesis. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3520 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HSX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4474 |
| Device | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Product Code | HSX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Knee Joint Femorotibial Metal/polymer Non-constrained Cemented Prosthesis. |
| CFR Regulation Number | 888.3520 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ARTHREX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BODYCAD LABORATORIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONSENSUS ORTHOPEDICS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDACTA INTERNATIONAL SA | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SMITH & NEPHEW INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMITH & NEPHEW, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 115 |
Adverse Event Without Identified Device Or Use Problem | 59 |
Fracture | 28 |
Migration Or Expulsion Of Device | 24 |
Break | 17 |
Failure To Adhere Or Bond | 14 |
Appropriate Term/Code Not Available | 14 |
Naturally Worn | 12 |
Difficult To Insert | 7 |
Device Dislodged Or Dislocated | 7 |
Unstable | 6 |
Malposition Of Device | 6 |
Migration | 5 |
Degraded | 5 |
Component Missing | 4 |
No Apparent Adverse Event | 4 |
Fitting Problem | 4 |
Device Contamination With Chemical Or Other Material | 4 |
Loosening Of Implant Not Related To Bone-Ingrowth | 4 |
Physical Resistance / Sticking | 3 |
Packaging Problem | 3 |
Mechanical Problem | 3 |
Difficult To Position | 3 |
Device Operates Differently Than Expected | 3 |
Patient-Device Incompatibility | 2 |
Tear, Rip Or Hole In Device Packaging | 2 |
Material Integrity Problem | 2 |
Loss Of Or Failure To Bond | 2 |
Noise, Audible | 2 |
Loose Or Intermittent Connection | 2 |
Device-Device Incompatibility | 2 |
Device Contaminated During Manufacture Or Shipping | 2 |
Device Packaging Compromised | 2 |
Mechanical Jam | 1 |
Plate | 1 |
Off-Label Use | 1 |
Device Issue | 1 |
Material Deformation | 1 |
Unintended Movement | 1 |
Loss Of Osseointegration | 1 |
Detachment Of Device Component | 1 |
Peeled / Delaminated | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Device Damaged Prior To Use | 1 |
Scratched Material | 1 |
Device Slipped | 1 |
Defective Device | 1 |
Detachment Of Device Or Device Component | 1 |
Crack | 1 |
Device Expiration Issue | 1 |
Delamination | 1 |
Incorrect Measurement | 1 |
Device Abrasion From Instrument Or Another Object | 1 |
Delivered As Unsterile Product | 1 |
Osseointegration Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Misconnection | 1 |
Human-Device Interface Problem | 1 |
| Total Device Problems | 397 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arthrex, Inc. | II | Nov-16-2017 |
| 2 | Blue Belt Technologies MN | II | Jun-27-2014 |
| 3 | Zimmer Biomet, Inc. | II | Mar-28-2018 |
| 4 | Zimmer Biomet, Inc. | II | Mar-14-2018 |
| 5 | Zimmer Biomet, Inc. | II | Jan-14-2018 |
| 6 | Zimmer Biomet, Inc. | II | Feb-22-2016 |